Customized surgical fixture

ABSTRACT

A customized surgical fixture ( 400 ) is formed by scanning a body to form a three-dimensional image of the body, and then identifying in the image a target ( 310 ) in the body, and mounting points or structures ( 330 ) on the body. A model, such as a computer solid model, of the fixture ( 400 ) is specified in accordance with the locations of the target ( 310 ) and mounting structures ( 330 ) or points. The fixture ( 400 ) is formed in accordance with the model of the fixture ( 400 ), for example using a rapid prototyping and tooling machine. When attached to the body, the fixture ( 400 ) can be used to guide a surgical instrument ( 610 ) into the body, for example, by using a mechanical guide ( 600 ) attached to the fixture ( 400 ) or using a remote sensing device ( 1300 ) that tracks the relative position of the customized fixture ( 400 ) and the surgical instrument.

This application is a continuation of 09/110,070 filed Jul. 6, 1998 nowU.S. Pat. No. 6,327,491.

BACKGROUND

The invention relates to customized surgical fixtures. Many types ofsurgical procedures rely on precisely guiding an instrument into thebody. This is the case in stereotactic surgery in which a target pointwithin a body, for example, within a brain, is identified in athree-dimensional scanned image of the body. A detailed survey ofstereotactic surgery can be found in Textbook of Stereotactic andFunctional Neurosurgery, P. L. Gildenberg and R. R. Tasker (eds.),McGraw-Hill, June 1997 (ISBN: 0070236046). In a typical approach tostereotactic surgery, a frame is attached to the body prior to scanning.After scanning, the target point in the body is identified in thescanned image with reference to the frame. Then, during surgery, anadjustable instrument guide is attached to the frame. The guide isadjusted to align with the target point. A related approach tostereotactic surgery is described in copending U.S. patent applicationSer. 09/063,658 filed Apr. 21, 1998, which is incorporated herein byreference. In that approach applied to brain surgery, an adjustableinstrument guide is attached directly to the skull. Once attached, it isadjusted to align with the target point.

These previous approaches to stereotactic surgery require adjustment ofan instrument guide in order that the instrument can be drivenaccurately to the target point within the body.

SUMMARY

Adjusting an instrument guide to align with a target point within thebody can be complex and time consuming. In some procedures multiplepoints must be targeted. For example, in spinal sterotactic surgery,multiple targets on different spinal segments are used. In a generalaspect of the invention, rather than targeting an adjustable instrumentguide, a customized fixture is fabricated for a particular patient, suchthat targeting is unnecessary or greatly simplified. A fixed instrumentguide attached to the customized fixture can be used to guide a surgicalinstrument to the desired point without adjustment.

In one aspect, the invention features a method for forming a surgicalfixture for attaching to a body and providing a reference structure forprecisely locating a target within the body, such as a particular pointor an anatomical structure within the body. The method includesprocessing a three-dimensional scanned image of the body, for example aCT or MRI scan. The scanned image includes the target within the body,for example a point or region of the body, and a mounting location ofthe body. The method also includes determining a structure of thesurgical fixture such that when attached at the mounting location of thebody the fixture provides a reference structure in a determined locationand orientation with respect to the target within the body.

The method can include one or more of the following features.

Multiple mounting points can be identified in the scanned image. Thegeometric relationship between corresponding mounting points on thefixture and the reference structure can then be determined. The methodcan further include attaching mounting anchors to the body prior toscanning the body. Scanning markers are attached to the anchors. Theidentified mounting points are then the locations of the scanningmarkers in the three-dimensional image.

The mounting location for the fixture can be an anatomical structure onthe body. A contour of a surface of the fixture is determined to matewith the anatomical structure.

The method can include identifying the target in the scanned image.Also, a trajectory for reaching the target can be identified. Thelocation and orientation of the reference structure is then determinedwith respect to the identified trajectory.

The structure of the fixture can be determined in terms of a solid modelof the fixture which defines the volume enclosed by the surface of thefixture. The method can then also include fabricating the fixtureaccording to the solid model.

The method can include attaching the surgical fixture to the body andguiding an instrument to the target with reference to the attachedsurgical fixture.

The method can include attaching the surgical fixture to the body andattaching multiple tracking markers to the surgical fixture. Forexample, the multiple tracking markers, such a light-emitting diodes,can be attached to a tracking fixture that is then attached to thesurgical fixture. The method then includes tracking locations of thetracking markers relative to a remote sensing device, such as a cameraarray or a laser tracker. The method can further include tracking alocation of a surgical instrument relative to the remote sensing device,for example by tracking locations of tracking markers attached to theinstrument, and computing a relative position of the surgical instrumentto the surgical fixture using the tracked location of the trackingmarkers and the surgical instrument relative to the remote sensingdevice.

The method can also include attaching a second surgical fixture at asecond mounting location of the body, and attaching multiple trackingmarkers to the second surgical fixture. For example, the two surgicalfixtures are attached at two mounting points on an articulated portionof the body, for example, on two bones coupled at a skeletal joint. Themethod then includes tracking locations of the tracking markers attachedto the second surgical fixture relative to the remote sensing device andcomputing a relative position of the two mounting locations of the bodyfrom the tracked locations of the tracking markers attached to bothsurgical fixtures. For example, a configuration of a skeletal joint canbe determined from the computed relative position of the mountinglocations.

The body can include a spine and the mounting location can include aspinal segment. The method can also include forming a model of thespine. The method can further include forming a corrected model of thespine in a corrected configuration. The determined structure of thesurgical fixture is such that when attached, the fixture provides asecond reference structure in a determined location and orientation withrespect to the target in the corrected configuration of the spine.

The method can include selecting a model of a standard fixture anddeforming the model of the standard fixture in order to match thestandard model to the target and the mounting location.

In another aspect, the invention features a surgical fixture formed froma computer model using a rapid prototyping and tooling technique. Thefixture includes multiple mounting sections for attaching the fixture toa body at a predetermined mounting location on a body and a referencestructure coupled to the mounting sections for guiding a surgicalinstrument into the body. When the fixture is attached to the body atthe mounting location the reference structure is at a predeterminedlocation and orientation to a target within the body. The fixture caninclude an instrument guide mounted on the reference structure fordriving the instrument into the body.

In another aspect, the invention features software stored on a computerreadable medium for causing a computer to perform the functions ofprocessing a three-dimensional scanned image of a body, the scannedimage including the target within the body and a mounting location ofthe body and determining a structure of a surgical fixture such thatwhen attached at the mounting location of the body the fixture providesa reference structure in a determined location and orientation withrespect to a target within the body.

Advantages of the invention include avoiding the need for targeting ofan adjustable guidance fixture based on the location of target pointswithin the body. This reduces the time required for surgery, and canincrease the accuracy and precision of targeting.

Another advantage is that the customized fixture can provide a mountingbase in a precise location relative to the body. This avoids a manualregistration procedure of stereotactic surgery in which a correspondencebetween the scanned image and the physical body is established. Themanual registration procedure can be time consuming and inaccurate.

Another advantage is that tracking markers, such as light sources orreflectors, can be attached at predetermined locations relative to thebody, without requiring that mounting points, such as bone anchors, arein a particular configuration, and without requiring a manualregistration step after the tracking markers are attached to the body.This provides flexibility in the choice of where to mount the fixtureand reduces the time required before surgery can begin and providesimproved accuracy compared to that typically achieved using manualregistration and avoids errors inherent in a manual registration step.

Another advantage is that the customized fixture is easily attached tothe body, for instance by mating the fixture to a set of anchorsattached to the body prior to scanning, or in another instance, matingthe fixture to the particular anatomy of the patient.

Another advantage is that the customized fixture can be repeatedlyreattached to permanently implanted anchors in the body allowingfollow-up or repeated procedures.

Another advantage of the invention is that the detailed fixture designcan be based on a desired configuration of a configurable portion of thebody, such as the spine, rather than solely on the configuration duringscanning. This allows the fixture to be used not only to guideinstruments into the body, but when attached to the body, to constrainthe configuration of the body, such as correcting a spinal or orthopedicbone deformity or complex fracture.

Other features and advantages of the invention will be apparent from thefollowing description, and from the claims.

DESCRIPTION OF THE DRAWINGS

FIGS. 1a-b show scanning markers and bone anchors used to attached thescanning markers to a skull;

FIG. 2 illustrates a scanning phase;

FIG. 3 illustrates a scanned image and located image points;

FIG. 4 illustrates a customized fixture;

FIGS. 5a-c illustrate another customized fixture, attached to a head,and viewed along a target trajectory and from the side;

FIG. 6 is a side view of a fixture supporting an instrument guide;

FIG. 7 is a side view of a fixture supporting an adjustable instrumentguide;

FIG. 8 illustrates a head-mounted fixture which mates with the contoursof the skull;

FIGS. 9a-b illustrate a customized fixture for spinal surgery;

FIGS. 10a-b illustrate a spinal fixture used to modify the curvature ofthe spine;

FIG. 11 illustrates a computer implementation of the fixture designprocedure;

FIG. 12 illustrates attachment of tracking markers to a customizedfixture;

FIG. 13 illustrates sensor-tracked image guidance of a surgicalinstrument relative to tracking markers attached to a skull with acustomized fixture; and

FIG. 14 illustrates multiple customized fixtures supporting trackingmarkers used to track the position of a femur relative to a pelvis.

DESCRIPTION

An approach to stereotactic surgery according to the invention involvesfour phases.

Scanning and Surgical Planning. A three-dimensional scanned image of apatient is taken. A surgeon identifies a target point or volume withinthe body and determines coordinates of the target in the image.

Fixture Design. Based on the scanned image and the identified targetpoint, a computer “solid model” of a customized fixture is computed. Thesolid model is computed so that the resulting fixture can be preciselyattached to the body. The fixture is further designed to include anintegral instrument guide, or a mounting base for a removable guide, foraccurately positioning a surgical instrument at the target point whenthe fixture is attached to the body.

Fixture Fabrication. Based on the computed solid model, the customizedfixture is fabricated using a computer controlled rapid prototyping andtooling (RPT) technique.

Surgery. The fabricated customized fixture is attached to the patient,and a surgical instrument is guided to the target point using thefixture.

Brain Surgery

A first embodiment of the invention is directed to brain surgery.Several alternative embodiments, described below, are also directed tobrain surgery. Additional related embodiments are also applicable toother types of surgery, including spinal surgery. The first embodiment,which is directed to brain surgery, is described below following thefour phases summarized above.

Scanning and Surgical Planning Phase

Referring to FIG. 1a, in the first phase, the scanning and surgicalplanning phase, a set of bone anchors 120 is attached to the skull 100prior to scanning the patient. In the illustrative example shown in FIG.1, three bone anchors 120 are attached to the skull. A greater orsmaller number of anchors can also be used. During the later surgicalphase, bone anchors 120 will be the attachment points for the fabricatedfixture.

Referring to FIG. 1b, each of the bone anchors 120 has a threadedopening for accepting threaded bolts or other threaded attachments. Inparticular, prior to scanning, each threaded opening is used to accept ascanning marker 122. Each scanning marker 122 includes a threadedsection 124 attached to a marker portion 126.

Marker portion 126 includes a material that will result in a visibleimage in the scanned image. Various types of scanning techniques can beused, including CT, PET, MRI, SPECT, and laser. The material in themarker portions 126 is chosen depending on the scanning technique thatwill be used.

Referring to FIG. 2, after scanning markers 122 are attached to boneanchors 120, the patient is scanned in a scanner 210 (illustratedschematically) producing a three-dimensional image 230. This image istransferred to a computer 220 where it is stored.

After the scanning process is complete, scanning markers 122 are removedfrom the patient, but bone anchors 120 are left firmly in place. In atypical situation, because the surgical phase of the process will notbegin for several hours, or even several days, the patient is allowed towalk around or even allowed to return home at this point.

Referring to FIG. 3, a surgeon plans the upcoming surgery using acomputer display of image 230 using well-known techniques instereotactic surgery. The surgeon identifies a target image point 310 inimage 230 corresponding to a target point in the body. The threedimensional coordinates of the target image point in the coordinatesystem of image 230 are stored on the computer. The surgeon alsoidentifies an entry image point 320 defining a straight-line trajectoryby which a surgical instrument can reach the target point while avoidingcritical structures in the brain. The coordinates of the entry imagepoint are also stored.

Referring still to FIG. 3, marker image points 330 in image 230correspond to the marker portions 126 of scanning markers 122 (FIG. 1b).The surgeon can locate these points using the computer display in asimilar manner to locating the target and entry points. Alternatively,an automated algorithm is implemented on computer 220 to locate markerimage points 330 based on the image characteristics, such as brightnessor shape, of the points. In either case, the coordinates in the image ofmarker image points 330 are stored.

At this point, based on a known correspondence of the scanned image tothe physical body, the locations of the actual target and entry pointson the body with respect to the locations of the scanning markers arecomputed and stored on the computer. This computation is based on thestored coordinates of the corresponding marker, target, and entry imagepoints.

A representation of the surface of the skull can be computed directlyfrom the scanned image using well-known image processing techniques.This surface representation can be used to ensure that a designedfixture will properly fit over the skull, or to determine othercharacteristics of the skull that may be used to design the fixture.

This completes the scanning and surgical planning stage.

Fixture Design Phase

The next phase of the process involves design and fabrication of thefixture itself. The design requirements of the fixture can be understoodby referring to FIG. 4 which shows how a fabricated fixture 400 will beattached to bone anchors 120 in the surgical phase. In this embodiment,fixture 400 is attached to bone anchors 120 using bolts 432 which passthrough openings 430 in fixture 400. When attached to the bone anchors,mounting points of fixture 400 are located at the prior locations of themarker portions 126 of scanning markers 122.

A planned actual trajectory 460 passes through an actual entry point 420to an actual target point 410 corresponding to the planned entry imagepoint 320 and target image point 310 (FIG. 3). Trajectory 460 passesthrough fixture 400 when attached to the skull.

Fixture 400 includes a way of mounting an instrument guide onto it toguide a surgical instrument along trajectory 460. In this embodiment,fixture 400 includes a mounting base 450 for attaching an instrumentguide. Mounting base 450 has a flat surface with a central opening. Whenfixture 400 is attached to the skull, trajectory 460 passes through thecentral opening of the mounting base and the flat surface of mountingbase 450 is perpendicular to trajectory 460. The distance between targetpoint 410 and the mounting base is also determined before the surgicalphase, for example by designing the fixture so that this distance is astandard distance related to the type of instrument that will be used.

The design of fixture 400 for a particular patient and surgicalprocedure must satisfy several constraints including one or more of thefollowing:

mounting base 450 is centered on the planned trajectory and orientedperpendicular to the trajectory,

the mounting points of fixture 400 mate with bone anchors 120,

the distance between target point 410 and the mounting base must be anexact distance or within a particular range related to the surgicalinstrument and guide that will be used,

the orientation of the fixture at each of the mounting points must beappropriate for the orientation of the corresponding bone anchors, and

the fixture must provide sufficient clearance above the skull whenmounted.

Referring to FIGS. 5a-c, an second exemplary fixture 500 is shownattached to the patient's head (FIG. 5a) and shown in a view along theplanned trajectory (FIG. 5b) and in cross section (FIG. 5c). Fixture 500is designed to attach to four bone anchors. Fixture 500 has a centralmounting base 550 in a center section 520. Four “legs” 510 extend fromthe center section to four mounting pads 530 with mounting holes 540through which fixture 500 is attached to the bone anchors.

The procedure for satisfying the constraints identified above uses analgorithmic approach. The approach can be understood with reference toFIGS. 5b-c. Referring to FIG. 5c, mounting base 550 is centered onplaned trajectory 460. In this example, the distance between targetpoint 410 and the center point 562 of the mounting base is set to apredetermined fixed distance.

Referring still to FIG. 5c, two of the mounting points 532 areillustrated along with the axes of the bone anchors. Mounting pads 530are designed as planar sections to lie over the mounting points and tobe perpendicular to the axes of the bone anchors. Legs 510 are thendesigned as planar sections that join mounting pads 530 and centersection 520.

In FIG. 5c, the surface of the skull 534 is illustrated along with entrypoint 420. The mounting pads, legs, and center section are design to lieabove and provide sufficient clearance above the skull.

In order to orient mounting pads 530 perpendicularly to the axes of thebone anchors, this approach to designing fixture 500 relies on knowledgeof the orientations as well as the locations of the bone anchors. In theapproach described above, as shown in FIG. 1b, a single marking portion126 is attached in scanning marker 122 to each bone anchor 120.Therefore only the location of each bone anchor is determined bylocating the marker images of the scanning markers.

One of several alternative approaches to determining the orientation ofthe bone anchors can be used. First, alternative scanning markers 122can be used. The alternative scanning markers have two marking portions126 separated along the axis of the scanning marker. Locating the imagesof both the marking portions determines the orientation of the boneanchor. A second alternative is to use a normal direction to a surfacemodels of the skull. The surface model of the skull can be computeddirectly from the scanned image using well known image processingtechniques. A third alternative is to approximate the orientation of thebone anchors by fitting a surface through the locations of the scanningmarkers, and optionally through the entry point. A fourth alternative isto not rely on the mounting pads being normal to the axes of the boneanchors, relying instead on a mounting approach that is less sensitiveto the orientation or the anchors. For instance, a ball can be mountedon each bone anchor and the fixture can have corresponding sockets whichmate with the balls.

Fixture 500 shown in FIGS. 5a-c is made up of essentially planarsections. Alternative algorithmic design approaches can be used todesign curved structures. For instance, the shape of the fixture can bedetermined using a surface spline with the mounting points and themounting base being points at which constraints on the coefficients ofthe splines are determined.

The design of the customized fixture is converted into a computerizedspecification of a solid model. A solid model is a computerrepresentation of a volume enclosed by a surface surrounding the entirevolume. Various types of computer representations of the volume can beused. A common format is an “.stl” file that is used by many computeraided design (CAD) systems. The stl file includes a set ofrepresentations of surface patches that together define a completesurface that encloses the volume. The stl file for the designed fixtureis then used as the specification for fabrication of the fixture.

Fixture Fabrication

The solid model file is transferred to a rapid prototyping and tooling(RPT) machine. The file can be transferred on a physical medium, such asa magnetic disk, sent over a data network, or used directly on thecomputer on which is was computed.

A variety of RTP techniques can be used to fabricate the fixture. Inthis embodiment, a Fused Deposition Modeling (FDM) machine, such modelFMD2000 manufactured by Stratasys, Inc. of Eden Prairie Minn., is usedto make the three dimensional fixture from the .stl file. The FDMmachine essentially robotically lays down a long ribbon of extrudedmaterial thereby slowly building up the modeled fixture. As material islaid down, it fuses with the previously laid down material making ahomogeneous solid. The process results in a highly accurate fixture,within 5 mil of the specification in the .stl file. Various materialscan be used for the fixture. In the embodiment, medical grade ABS isused.

After fabrication in the FDM machine, some further machining may beneeded for some fixture designs. For instance, the ABS material can bedrilled and tapped to provide mounting points at which an instrumentguide is attached.

Surgery

The completed fixture is returned to the surgeon. The patient returns,with the bone anchors still intact, for the surgical phase. The fixtureis sterilized and then the surgeon attaches the sterilized fixture tothe bone anchors in the patient's skull and begins the surgical phase.

The surgical phase for brain surgery involves several steps, includingopening a burr hole, and the inserting of an instrument in the burrhole. The burr hole can be drilled prior to attaching the fixture, orcan be drilled using the fixture. In the latter case, a drill guide isattached to the mounting base and a drill is inserted through the drillguide to drill the burr hole at the planned entry point.

Referring to FIG. 6, to insert a surgical instrument into the brain toreach the planned target point, fixture 400 is used to support aninstrument guide 600. In the illustrative example shown in FIG. 6,instrument guide 600 supports an insertion tube 620 through which aninstrument 610, such as a recording electrode, is passed. The instrumentis attached to a drive 630 on instrument guide 600 for manually orautomatically driving the instrument to target point 410. Since theseparation of target point 410 and mounting base 450 is specified whenthe fixture is designed, if the length of the surgical instrument ispredetermined, then the instrument guide can be calibrated to preciselyinsert the instrument to the target point. For instance, if theinstrument is known to have a standard length, the separation of thetarget point and the mounting base on the fixture can be designed suchthat when the instrument drive is in its fully inserted position, theinstrument has reached the planned target point.

Alternative instrument guides can be used in conjunction with a customfabricated fixture. Referring to FIG. 7, an adjustable instrument guide700 is attached to mounting base 450. The instrument guide is adjustableallowing the actual trajectory of instrument 610 to fall within a conewith an apex at entry point 420. For instance, an adjustable guidancefixture such as one described in copending U.S. patent application Ser.No. 09/063,658 filed Apr. 21, 1998 or Provisional Application 60/096,384filed Aug. 12, 1998 can be used. Both of these copending applicationsare incorporated herein by reference.

Note that since adjustable instrument guide 700 is attached in a preciserelationship to target point 410 and entry point 420, a “registration”step of the type typically carried out in stereotactic surgery, used toconformally map a physical coordinate system to an image coordinatesystem, is not needed. Furthermore, instrument guide 700 can includeencoders that generate signals which encode the adjustment of the actualtrajectory relative to the planned trajectory, allowing precise visualfeedback to be computed and displayed to a surgeon. Instrument guide canalso be actuated allowing remote or robotic control of the instrumentand the guide.

Alternative Approaches

In the embodiment described above, the fabricated fixture is attached tobone anchors. Alternative embodiments attach the fixture to the body indifferent ways. For instance, other types of inserts or bone anchors canbe attached to the skull. Also, rather than attaching the fixture to abone anchor, the fixture can be designed to precisely clamp onto thepatient's head. For example, referring to FIG. 8, two mating halves 810,820 of a fixture 800 match the contours of cheek bones and forehead, andthe contours of the back of the head, respectively. The contours of thepatients head are derived from the a model of the skull that is computedautomatically from the scanned image.

In the embodiments described above, the design (i.e., the solid model)of the fixture is determined algorithmically from the locations andorientations of points, including the mounting points, the target pointand the entry point. An alternative approach to design of the fixtureinvolves interaction with the surgeon. Rather than having to specify adetailed design for the fixture, the surgeon has control over a limitednumber of deformations of a standard fixture.

A particular implementation of this deformation procedure uses arelational geometry approach. U.S. Pat. No. 5,627,969 issued Mar. 17,1995 to John S. Letcher, Jr., describes such a relational geometryapproach and software architecture to implement the approach.

A set of “standard” fixtures are used as the basis of the procedure.Each of the standard fixtures is described using a “logical model” inwhich geometric relationships of various elements of the fixture areexplicitly identified. Examples of constraints described in the logicalmodel include the shape of the mounting base (which is not deformed),and the connections of sections such as the mounting legs and centralsection.

In the fixture design phase, the surgeon selects one of the standardfixtures. Using a computer aided graphic design (CAGD) tool, the surgeonviews both a representation of the body and a representation of thefixture. Initially, the standard fixture does not satisfy any of thedesign constraints. Using the CAGD tool, the surgeon adjusts the fixturedesign so that the fixture will mate with the bone anchor, and so thatthe mounting base will have the correct location and orientation withrespect to the entry and target points. Furthermore, the surgeon canadjust other aspects of the design, for example, deforming the fixtureto allow sufficient clearance for an ear.

Spinal Surgery

Another embodiment of the invention is directed to spinal surgery. As inthe brain surgery approach, a three-dimensional scanned image is takenof the patient, in this case of his or her spine. In this embodiment, noanchor points or scanning markers are necessarily applied to the spine,however.

Referring to FIG. 9a, using techniques well known in stereotactic spinalsurgery, the surgeon identifies target points 934 in the image of aspine 920, for example, points at which screws are to be inserted intothe spine. The surgeon also plans trajectories 932 to reach the targetpoints, for example determining the angles at which the screw holes willbe drilled.

Using well-known image analysis and modeling techniques, a computermodel of the segments of the spine 920 is formed from the scanned image.

The surgeon identifies two segments 922 to which a customized fixture900 is to be attached. Referring to FIG. 9b, the models of segments 922are used to form clamp sections which mate with the contours of thesegments. A portion 910 of the clamp section is formed in one piece withthe main section of the fixture. A second portion 912 of each clampsection is formed as a separate component. The two portions of the clampsection are drawn together to attach the fixture to the spinal segments.Fixture 900 is formed to match the curvature of spine 920 as it isscanned. For instance, the separation of segments 922 matches theseparation in the scanned image.

For each of the target points, a separate instrument guide 930 is formedin fixture 900. For example, each instrument guide can be a elongatedhole into which a drill is inserted. The instrument guides can bedesigned so that not only the orientation but also the depth of theholes drilled into the spinal segments are precisely determined by theinstrument guides.

After attaching the fixture, the surgeon proceeds with the operations oneach of the spinal segments that are involved in the overall surgerywithout repositioning fixture 900.

In an alternative embodiment directed to spinal surgery, previouslyapplied anchors and scanning markers in spinal segments or bonystructures are used to define the geometry of a customized fixture sothat it mates with these anchors.

Another embodiment directed to spinal surgery not only addressesoperations to be performed on the spine in the configuration that it wasscanned, but also address manipulating the spine to a desired curvaturedifferent from that in the scanned image. In addition to forming acomputer model of the spine as it is scanned, a modified spinal model isalso derived. The modified model represents the desired curvature of thespine. A second fixture is designed according to the modified model.After the first fixture is removed, the second fixture is attached toachieve the desired curvature of the spine.

A related embodiment is illustrated schematically in FIG. 10a-b. Thisembodiment also uses the modified spinal model. However, rather thanforming a second fixture, additional guides 1010 are formed in the firstfixture for the purpose of manipulating the spine into the desiredconfiguration. For example, in addition to guides 1020 which are formedalong the orientations 1022 to drill the segments, additional guides1010 are formed in the fixture corresponding to the orientations 1012 ofthe drilled holes after modification of the curvature, and screwsinserted into the holes can be forced to lie in the desiredorientations. Similar embodiments can be applied to correction andrepair of orthopedic bone or joint deformity or fracture.

Other Surgical Procedures

The embodiments presented above are described in the context ofstereotactic brain or spine surgery. Similar approaches are applicableto other types of stereotactic surgery.

Similar customized fixtures are also applicable to other types ofsurgical procedures in which a device must be precisely attached to abody. For instance, a precise instrument guide can be mounted withreference to facial features for eye surgery.

Sensor-Tracked Image Guidance

In other alternative embodiments, one or more customized fixtures areused to support tracking markers that are used in sensor-trackedimage-guided stereotactic surgery. Referring to FIG. 12, in an exemplaryembodiment in which tracking markers are used, bone anchors 120 areattached to a body. In a procedure of the type described above, scanningmarkers are attached to the bone anchors, and the precise location ofthe bone anchors relative to the body are determined from a scannedimage.

Referring still to FIG. 12, a customized fixture 1200 is fabricated sothat it has a known geometry relative to the mounting points which matewith bone anchors 120. In this embodiment, a tracking fixture 1210 isattached to customized fixture 1200. Tracking fixture 1210 has a numberof tracking markers 1215 attached to it. These markers are trackedduring surgery. Tracking markers 1215 light-emitting diodes, or otheremitters or reflectors of energy, whose three-dimensional location canbe tracked using a remote sensing device, such as a camera array or alaser tracker.

Referring to FIG. 13, tracking fixture 1210 is shown rigidly mounted tothe body through bone anchors 120. The locations of bone anchorsrelative to the body is determined from the scanned image. The geometryof customized fixture 1200 is determined in the fixture design phase.The location of tracking markers 1215 on tracking fixture 1210 are knownfrom the predetermined geometry of the tracking fixture. The locationsof tracking markers 1215 relative to bone anchors 120 are then computedfrom the geometry of the customized fixture and the geometry of thetracking fixture attached to it, in what is essentially a “computedregistration” step.

Referring still to FIG. 13, a surgical instrument 1310, for example amanually positioned probe, also includes multiple tracking markers 1315.A tracking system, which includes a remote sensing device 1300, in thiscase a camera array, is used to track the three-dimensional locations oftracking markers 1215 and 1315. Using a predetermined geometry ofsurgical instrument 1310, including the locations of tracking markers1315 on the instrument, and the determined locations of tracking markers1215 relative to the bone anchors. The tracking system is used tocompute the relative position of the surgical instrument to the body.The tracking system displays a representation of surgical instrument1310 on display system 1320 in a proper position and orientationrelative to an image of the body.

Note that a manual registration phase of the type generally performedprior to conventional image-guided stereotactic surgery is not needed todetermine the relative position of the instrument to the body. However,the computed registration step described above can be validated ordouble-checked using a manual procedure, for example, by touching theend of the surgical instrument to predetermined locations, such as thelocations of the bone anchors, and verifying that the tracking systemcorrectly calculates the locations. Furthermore, remote sensing device1300 does not have to remain in a fixed location relative to the body,and in fact, both the body and sensing device 1300 can be freely movedaround while continually tracking the location of the surgicalinstrument relative to the body.

Referring to FIG. 14, in another alternative embodiment, multipletracking fixtures 1210 are used. Tracking fixtures 1210 are rigidlyattached to segments of an articulated portion of the body to track therelative positions of those segments. In one exemplary use of multipletracking fixtures, as shown in FIG. 14, one tracking fixture 1210 isattached to a pelvis 1410 using a first customized fixture 1420, while asecond tracking fixture 1210 is attached to a femur 1430 using a secondcustomized fixture 1440. Customized fixtures 1420 and 1440 are designedand fabricated in the manner described above to mate with mountinganchors or screws on the pelvis and femur. For instance, anchoringscrews 1442 are inserted into femur 1430. Scanning markers are attachedto anchoring screws 1442 prior to scanning. Customized fixture 1440 isdesigned to have a known geometry and to mate with anchoring screws1442. Customized fixture 1420 is similarly designed to mate with boneanchors that have been inserted into the pelvis.

During surgery, remote sensing device 1300 is used to determined therelative position and orientation of the two tracking fixtures 1210.Based on the computed registration of each tracking fixture to the rigidpart of the body to which it is attached, the tracking system computesthe relative position and orientation of femur 1430 and pelvis 1410 anddisplays representations of the femur and the pelvis on a display system1450 in their proper geometric relationship.

Similar customized fixtures are used to attach tracking fixtures toother parts of the body, for example to mulitple segments of the spine.Multiple tracking fixtures can also be used to track the configurationof skeletal joints during surgery or during other medical procedures.

In embodiments described above, tracking fixtures, which have integratedtracking markers, are attached to customized fixtures. Alternatively, acustomized fixture can be designed and fabricated to directly hold thetracking markers, thereby being a customized tracking fixture (or“tracking frame” ), which has a predetermined geometric relationshipbetween the mounting points of the fixture and the locations of thetracking markers.

Implementation

Referring to FIG. 11, the design and fabrication of the fixture involvesseveral steps and pieces of equipment. Scanner 210 produces scannedimage 230 which is passed to computer 220. Computer 220 is used by thesurgeon to identify target and entry points, and possibly other pointssuch as marker image points. A display and input device 1110 provides aninterface for the surgeon. For instance, multiple planar views of thescanned image are presented to the surgeon, and the surgeon selectspoints using a mouse. Program storage 1125 is coupled to computer 220for holding software used to implement procedures executed by computer220. As described above, a library of standard fixtures 1120 canoptionally be attached to computer 220. These standard fixtures aredeformed using interactive procedures implemented on computer 220.

The product of the procedures executed on computer 220 is solid model1130 which completely specifies the shape of the fixture. This model ispassed to a fabrication computer 1140 which derives tooling instructions1150 which are passed to the RPT machine 1160. The RPT machinefabricates the fixture according to the tooling instructions.

It is to be understood that the foregoing description is intended toillustrate and not limit the scope of the invention, which is defined bythe scope of the appended claims. Other embodiments are within the scopeof the following claims.

What is claimed is:
 1. A method for forming and using a customizedfixture comprising: determining data characterizing a plurality ofattachment locations on a body; computing a digital model of the shapeof the customized fixture, including determining said shape to mate withthe attachment locations on the body and determining a location forattaching a tracking device to the fixture; and computing registrationdata that is sufficient to relate coordinates of a point in an internalcoordinate system that is fixed relative to the attachment locations onthe body with coordinates of said point in an external coordinate systemin which a position of the tracking device that is attached to the bodyusing the customized fixture is known.
 2. The method of claim 1 furthercomprising using the registration data to relate coordinates of a pointin the internal coordinate system and coordinates of said point in theexternal coordinate system.
 3. The method of claim 2 wherein using theregistration data includes transforming the coordinates of the point inthe internal coordinate system to coordinates of said point in theexternal coordinate system.
 4. The method of claim 2 wherein using theregistration data includes transforming the coordinates of the point inthe external coordinate system to coordinates of said point in theinternal coordinate system.
 5. The method of claim 4 further comprisingusing the coordinates of the point in the internal coordinate system todisplay a representation of the point in conjunction with a graphicalimage of the body.
 6. The method of claim 4 wherein the point in theexternal coordinate system corresponds to a point that is fixed relativeto an instrument that is free to move relative to the body.
 7. Themethod of claim 6 further comprising tracking a position of the trackingdevice and a position of the instrument in the external coordinatesystem.
 8. The method of claim 1 further comprising determining datacharacterizing the physical structure of the body by processing athree-dimensional scan of the body.
 9. The method of claim 2 whereindetermining data characterizing the attachment locations on the bodyincludes identifying the attachment locations using the datacharacterizing the physical structure of the body.
 10. The method ofclaim 9 wherein determining data characterizing the attachment locationsincludes determining positions of a plurality of bone anchors that wereattached to the body at the time the three-dimensional scan wasgenerated.
 11. The method of claim 9 wherein determining datacharacterizing the attachment locations includes identifying a contourof a surface of the body for mating with the customized fixture.
 12. Themethod of claim 1 further comprising providing the customized fixture.13. The method of claim 12 wherein providing the customized fixtureincludes fabricating the customized fixture according to the digitalmodel.
 14. The method of claim 12 wherein fabricating the customizedfixture includes forming a unitary structure of the fixture using acomputer-controlled process.
 15. The method of claim 14 wherein formingthe unitary structure includes using a rapid prototyping and tooling(RPT) technique.
 16. The method of claim 12 further comprising attachingthe tracking device to the customized fixture at the determined locationfor attaching the tracking device.
 17. The method of claim 16 whereinattaching the tracking device includes attaching a tracking frame thatincludes a plurality of tracking markers.
 18. The method of claim 16wherein the tracking device includes a plurality of tracking markers andattaching the tracking device includes attaching each of the trackingmarkers directly to the customized fixture.
 19. The method of claim 16further comprising attaching the customized fixture to the body bymating the mounting points with the mounting locations.
 20. The methodof claim 19 wherein the mounting locations include bone anchors attachedto the body and attaching the customized fixture includes attaching thefixture to the bone anchors.
 21. The method of claim 19 furthercomprising tracking a position of the tracking device in the externalcoordinate system.
 22. The method of claim 21 wherein the trackingdevice includes a plurality of tracking markers and tracking theposition of the tracking device includes tracking each of the markersrelative to a sensing device.
 23. The method of claim 22 wherein theexternal coordinate system is fixed relative to the sensing device andtracking each of the markers includes determining coordinates of themarkers in the external coordinate system.
 24. Software stored on acomputer readable medium for causing a computing system to performfunctions comprising: determining data characterizing a plurality ofattachment locations on a body; computing a digital model of the shapeof a customized fixture, including determining said shape to mate withthe attachment locations on the body and determining a location forattaching a tracking device to the fixture; and computing registrationdata that is sufficient to relate coordinates of a point in an internalcoordinate system that is fixed relative to the attachment locations onthe body with coordinates of said point in an external coordinate systemin which a position of the tracking device that is attached to the bodyusing the customized fixture is known.
 25. The software of claim 24wherein the functions further comprise using the registration data torelate coordinates of a point in the internal coordinate system andcoordinates of said point in the external coordinate system.